Significant Event Analysis - Guidance for Primary Care Teams - NHS Scotland
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Significant Event Analysis Guidance for Primary Care Teams
Significant Event Analysis Guidance for Primary Care Teams
The development of this Significant Event Analysis guidance
was jointly undertaken by NHS Education for Scotland and the
National Patient Safety Agency, with support from the Royal
College of General Practitioners and Healthcare Improvement
Scotland.
Authors
Paul Bowie PhD
Associate Adviser in Postgraduate GP Education
NHS Education for Scotland
Carl de Wet MRCGP MMed
Safety & Improvement Adviser
NHS Education for Scotland
Michael Pringle MD FRCGP
Professor of General Practice
University of Nottingham
© NHS Education for Scotland 2011. You can copy or reproduce the information in this
document for use within NHSScotland and for non-commercial educational purposes. Use of
this document for commercial purposes is permitted only with the written permission of NES.
NHS Education for Scotland 1 Contents Foreword........................................................................................................................2 Purpose and background.........................................................................................3 A quick guide to conducting a Significant Event Analysis............................4 A full guide to an effective Significant Event Analysis . ................................6 Stage 1 – Awareness and prioritisation of a significant event ................ 10 Stage 2 – Information gathering........................................................................ 11 Stage 3 – The facilitated team-based meeting ............................................ 12 Stage 4 – Analysis of the significant event .................................................... 14 Stage 5 – Agree, implement and monitor change ...................................... 19 Stage 6 – Write it up............................................................................................... 20 Stage 7 – Report, share and review................................................................... 21 Quick pointers to writing up SEA reports and examples........................... 23 Linking reflection, personal development and regulation......................... 34 A brief history of SEAs............................................................................................ 35 References ................................................................................................................ 37 Further reading......................................................................................................... 38 Useful web links........................................................................................................ 39 Appendix 1................................................................................................................. 40 Appendix 2 ............................................................................................................... 43
2 Significant Event Analysis Guidance for Primary Care Teams
Foreword
To err is human, to cover up is unforgivable
and to fail to learn is inexcusable
Liam Donaldson (2004)
General practice and primary care have not traditionally been regarded
as fertile ground for innovations in patient safety, with most interest and
attention generally focused on developments relating to care in the acute
sector. However, with Significant Event Analysis (SEA), general practice
can be proud to claim that the introduction and development of this
technique arose from work by two GPs, Mike Pringle and Colin Bradley.
Moreover, the publication of their pioneering work, in the form of a Royal College of
General Practitioners (RCGP) Occasional Paper, dates from the 1990s, well in advance of
many of the seminal works that have facilitated the global spread of the patient safety
movement. Since then, I am proud to say that NHS Education for Scotland (NES) has
been arguably the leading light in further developing and investigating the application
of the SEA technique in primary care and beyond. In doing so, NES research has made
a major contribution to the international evidence base on the use of SEA by healthcare
teams and its impact on learning, safety and improvement.
This publication is the result of partnership working between a number of individuals
and organisations across the United Kingdom and should mark a new phase in the
development of SEA. This is no longer an exercise conducted occasionally, in a small
number of practices, but a mainstream activity that all practices engage in regularly,
with identifiable benefits for patients and the healthcare team. It is integral to the
demonstration of reflective practice for the Quality & Outcomes framework and annual
GP appraisal, and it will be important evidence for revalidation. It is also an activity where
genuine multidisciplinary engagement can be demonstrated, as befits professionals
working together in primary care teams. Importantly, SEA will play a key role in
supporting the primary care goals of the Scottish Patient Safety Programme and the
recently published Quality Strategy.
Primary care teams can use this guidance to consider:
whether they can do more to improve the effectiveness of the SEAs they undertake
the clear benefits to be gained from adopting a more in-depth analytical approach
when using SEA.
It may also be time for local NHS Boards and primary care teams to consider whether
others could learn from the vast numbers of SEAs carried out. Sharing the learning from
these events more broadly would be a significant step for patient safety improvement
efforts given our limited knowledge of what can go wrong and why, and how we can
resolve many of these issues.
I wholeheartedly commend this educational guidance to all GPs and primary care teams in
NHSScotland.
Professor T S Murray
National GP Director
NHS Education for Scotland
NHS Education for Scotland 3 Purpose and background Purpose This guidance will enable you and your team to conduct an effective Significant Event Analysis (SEA) with the aim of improving health care and the patient experience. Effective SEAs allow you and your team to highlight and learn from both strengths and weaknesses in the care you provide.1,2,3 The aim of this document is to provide you with guidance on how to develop a structured and effective SEA process that can be embedded as an improvement tool within your practice. We do this by defining the process, outlining effective practices and demonstrating what can be achieved through real life examples. Background Improving the quality and safety of patient care is a key clinical governance priority in primary healthcare. SEA has an important role to play in contributing to this aim and this is reflected in its inclusion as part of the Quality and Outcomes Framework (QOF), GP Appraisal and proposals for revalidation being developed by the Royal College of General Practitioners (RCGP). The National Patient Safety Agency (NPSA) in Seven steps to patient safety for primary care (www.npsa.nhs.uk/nrls/improvingpatientsafety/patient- safety-tools-and-guidance/7steps/) strongly recommends that SEAs should be routinely undertaken by primary care teams. By doing so, patients, carers and the public can be reassured that care is being quality assured and, where appropriate, lessons are being learnt and improvements are implemented. Most primary care teams have, traditionally, not been good at learning effectively from when things go wrong or when not so good practices are highlighted. Taking part in SEAs offers the care team a chance to hold regular structured meetings and to reflect on individual events that are identified as being ‘significant’ to them. Importantly, the opportunity for reflection, discussion and analysis helps the team (and individual healthcare professionals) to identify learning needs and share good practices. Another major advantage of doing an SEA well is that it can enhance team-working and morale, and improve communication between team members and others.
4 Significant Event Analysis Guidance for Primary Care Teams
A quick guide to conducting a
Significant Event Analysis
The seven stages of Significant Event Analysis
Stage 1 Awareness and prioritisation of a significant event
Staff should be confident in their ability to identify and prioritise a significant
event when it happens.
The Practice should be fully committed to the routine and regular analysis of
significant events.
Stage 2 Information gathering
Collect and collate as much factual information on the event as possible from
personal testimonies, written records and other healthcare documentation.
For more complex events, an in-depth analysis will be required to fully
understand causal factors.
Stage 3 The facilitated team-based meeting
The team should appoint a facilitator who will structure the meeting, maintain
basic ground rules and help with the analysis of each event. The team should
meet regularly to discuss, investigate and analyse events. These meetings are
often the key function in co-ordinating the SEA process and they should be
held in a fair, open, honest and non-threatening atmosphere.
Agree any ground rules before the meeting starts to reinforce the educational
spirit of the SEA and ensure opinions are respected and individuals are not
‘blamed’.
Minutes of the meeting should be taken and action points noted. These
should be sent to all staff, including those unable to attend the meeting.
An effective SEA should involve detailed discussion of each event,
demonstration of insightful analysis, the identification of learning needs and
agreement on any action to be taken.
NHS Education for Scotland 5
Stage 4 Analysis of the significant event
The analysis of a significant event can be guided by answering four questions:
1. What happened?
2. Why did it happen?
3. What has been learned?
4. What has been changed or actioned?
The possible outcomes may include:
no action required;
a celebration of excellent care;
identification of a learning need;
a conventional audit is required;
immediate action is required;
a further investigation is needed;
sharing the learning.
Stage 5 Agree, implement and monitor change
Any agreed action should be implemented by staff designated to co-ordinate and
monitor change in the same way the practice would act on the results of ‘traditional’
audits.
Progress with the implementation of necessary change should always be monitored
by placing it on the agenda for future team or significant event meetings.
Where appropriate, the effective implementation and review of change is vital to
the SEA process. To test how well the SEA process has gone, practices should ask
themselves ‘What is the chance of this event happening again?’.
Stage 6 Write it up
It is important to keep a comprehensive, anonymised, written record of every
SEA, as external bodies will require evidence that the SEA was undertaken to a
satisfactory standard. The SEA report is also a written record of how effectively the
significant event was analysed.
Stage 7 Report, share and review
Reporting when things go wrong is essential in general practice, but rarely happens.
The practice should look to formally report and notify (via the local primary
care organisation) those events where patient safety has, or could have been,
compromised.
Where a mechanism exists, practices should share knowledge of important
significant events with local clinical governance leaders so that others may learn
from these.
6 Significant Event Analysis Guidance for Primary Care Teams
A full guide to an effective
Significant Event Analysis
What is a significant event?
A common question often posed by primary care teams is: ‘What
exactly is a significant event’? The original definition by Pringle and
colleagues (see box below) is very broad. It is important to remember
that a significant event offers an important opportunity for reflection and
learning. More often than not it will highlight a negative experience for
patients, relatives, clinicians and others. However, we can learn as much
from good practice as from bad practice.
Examples could range from a serious patient safety incident (e.g. a medication error
leading to death), to a moderate level error (e.g. failure to act on laboratory findings
resulting in a four-week delay in a diagnosis), to an event which demonstrates excellent
care provision (e.g. rapid diagnosis of unexpected malignancy in a fit young man), to one
of a seemingly trivial nature which has serious administrative consequences (e.g. failing to
change a recorded message on a Bank Holiday weekend).
Definition of a significant event
Any event thought by anyone in the team to be significant in the care of
patients or the conduct of the practice.1
The interchangeable use of safety-related terminology (critical incident, error, near miss,
adverse event and so on) by health professionals can cause confusion. All are ‘significant
events’. In one sense, because the definition of a significant event is all-embracing, this
can make it easier for us to identify those issues where there are important learning
opportunities for the team.
Examples of incidents that could trigger a Significant Event Analysis
Diagnoses Events Screening
New diagnoses of cancer, . Unplanned pregnancies Positive cervical smears
Ischaemic Heart Disease (for contraceptive advice)
(IHD) or stroke (for
prevention, acute care and
follow-up)
Meningitis, measles, mumps, Unexpected deaths Positive mammography
rubella, pertussis, bacteria
gastro-enteritis .
(for prevention)
Acute asthma, epileptic fits Palliative and terminal care
and parasuicide (for prior
care)
Low impact fractures
NHS Education for Scotland 7
Prescribing errors Communication Investigations and
results
Wrong drug prescribed Appointment letter sent . Urgent referral not done
to wrong address
Wrong drug dose Wrong information given . Result mis‑filed
over telephone
Drug interaction Important message not Result not acted on
acted on
Inadequate drug monitoring Investigation request not
Misinterpretation of a sent
handwritten prescription
Appointments Acute cases, Patient and family
and surgeries emergencies and
harm
Unannounced extra Acute asthma Patient expelled from
practice
Emergency line engaged/ Suspected meningitis Termination request
rang out
Registrar on alone Non-accidental injury Domestic abuse issues
Limited GP cover Sudden unexpected death Angry or upset
General Disease diagnosis Home visits and
administration and management external care
Equipment failure Poor control of Visit request not done
International Normalised
Ratio (INR)
Computer data loss Failure to follow-up Mix-up over request
urgency
Target payment failure Delayed diagnosis Wrong address of patient
Complaint about premises Wrong treatment given Out-of-hours issue
8 Significant Event Analysis Guidance for Primary Care Teams
Examples of interesting, complex and good practice events
Reflection Reflection Reflection
interesting case terminal illness complex case
A review of a patient who Review of a patient with A ‘heart-sink’ patient with
had multiple investigations a prolonged terminal multiple non-organic
and referrals and who illness with bowel cancer problems who also
turned out to have a highlighted the difficulties developed IHD.
phaeochromocytoma. in managing vomiting and
pain control.
Reflection Reflection Reflection
successful early unexpected appreciation
cardio-pulmonary diagnosis of cancer
resuscitation
in the surgery
A practice team reviews A middle-aged female A thank you letter to all
the successful cardio- who had presented with of the surgery staff from
pulmonary resuscitation of a vague history of lower the family of a patient
a middle-aged man who abdominal pains. Referred who had died.
collapsed in the surgery for a ‘soon’ ultrasound
waiting area. which identified an early
stage ovarian cancer.
Learn more about what can go wrong in primary care
A summary of selected studies and their findings which provides some
insights into what can go wrong in general practice is outlined in Appendix 1.
Also see Appendix 2 for case scenarios of significant events.NHS Education for Scotland 9
What is a Significant Event Analysis?
Put simply, an SEA is a ‘qualitative’ method of clinical audit. In this respect it differs from
the ‘traditional’ process of audit which most primary care teams will be familiar with: for
example, when reviewing and improving care in the management of diabetes, asthma,
IHD, or hypertension. These audits tend to deal with larger-scale ‘quantifiable’ patient
data sets and involve defining criteria and setting standards which can be measured
and compared against. However, SEA should involve a systematic attempt to investigate,
review and learn from a single event that is deemed to be ‘significant’ by the healthcare
team.
Often, these types of ‘significant events’ will not be highlighted through ‘normal’ audit,
but they still offer the primary care team valuable opportunities to improve the quality
and safety of healthcare. An SEA provides us with a structured framework which can guide
the primary care team when discussing and investigating a chosen significant event.
Pringle’s SEA definition:
A process in which individual episodes (when there has been a significant
occurrence either beneficial or deleterious) are analysed in a systematic and
detailed way to ascertain what can be learnt about the overall quality of care,
and to indicate any changes that might lead to future improvements.1
The seven stages of Significant Event Analysis
In preparing and planning SEAs, the GP team should follow seven different stages (see
following pages) in identifying, investigating and analysing a significant event. Closely
adhering to each stage of the process helps to ensure that the team undertakes a more
in-depth and enjoyable SEA experience.10 Significant Event Analysis Guidance for Primary Care Teams
Stage 1 Awareness and prioritisation
of a significant event
Staff should be confident in their ability to identify a significant event
when it happens, and the practice should be fully committed to the
routine audit of significant events, either through dedicated meetings
or as an agenda item at other practice meetings.
The practice should have a simple computer or paper-based system for logging all
significant events identified by clinicians and staff.
Designated practice staff can be consulted by others and are able to make a judgement
on whether a specific significant event should be formally analysed immediately, at the
next routine meeting, or can be dealt with in a simpler way. Alternatively, all possible
events are listed and the prioritisation, if required, takes place at the start of the routine
SEA meeting.
In primary care, most incidents or events which result in either no harm to the patient or
low to moderate harm should be reviewed using an SEA.
Guidance on topic selection for an SEA and team
participation
Prioritise significant events for audit based on their consequences (actual or
potential) for the quality and safety of patient care. The opportunity for learning and
improvement, where required, should also be clearly apparent. Not all significant
events need to be formally audited. A decision on whether a significant event
should be formally audited should be made after discussion with colleagues.
Events which are concerned with under-performance, contractual or personal
issues should be dealt with through existing practice procedures, rather than by an
SEA.
Some events, particularly clinical examples, will undoubtedly be highly sensitive and
GPs may not be prepared to highlight these to the whole practice team, especially
if team-based input is not necessarily relevant or required. This is fine as long as
the SEA process is still applied in conjunction with close clinical colleagues and
that insight, learning and necessary change are demonstrated. In the past, analysis
of these events may have been avoided and taken off the SEA agenda. However,
in the current climate where learning from patient safety incidents is paramount,
these types of events can no longer be ignored.
Events selected for audit may be heavily clinical in nature, which tends to alienate
non-clinical staff. Be flexible – there is nothing to stop administrative staff meeting
as a group occasionally to audit administrative significant events and reporting the
outcomes at future, full, team-based meetings.
Ultimately, it is for each team to decide who is invited. While the doctors, nurses
(practice and community) and senior managers are normally invited, receptionists
and administrators might also be present. There has to be a balance between those
who can contribute to an honest discussion, and creating such a large group that
discussion of sensitive issues, such as clinical errors, is inhibited.NHS Education for Scotland 11
Stage 2 Information gathering
The information gathering process can begin immediately after the
event, just prior to the routine SEA meeting, or it can happen during
the meeting. Where time permits, the team should attempt to determine
exactly what happened, how it happened and why it happened for each
event before the routine meeting. This may be particularly important
for serious or complicated events in order to allocate greater time at
the meeting to understanding the causes of these events and agreeing
action points. The individual(s) involved, directly or indirectly, in the
event may be best placed to lead the investigation, but others can also
be delegated this task.
Collect and collate as much factual information on the actual event as possible, from
medical records, personal accounts and other clinical documentation. This is necessary
in order to build a timeline of the key factors which contributed to the significant event.
Personal accounts will be gathered through the thoughts, opinions and impressions of
those directly and indirectly involved, including (where relevant) patients and relatives or
health professionals who are not part of the immediate team.
Occasionally, when an event is discussed at a team meeting, it may become obvious
that it is too complex to be immediately understood and resolved. The outcome of such a
meeting is a recommendation that a more in-depth investigation is therefore required (see
Stage 4).
Common information sources:
Case records, laboratory reports, letters of complaint, practice protocols and
other relevant documentation.
Personal testimony from patients, relatives, healthcare staff and individuals from
other agencies.12 Significant Event Analysis Guidance for Primary Care Teams
Stage 3 The facilitated team-based
meeting
An SEA normally involves a routine meeting of all relevant team members
to discuss, investigate and analyse the significant event(s). The team-
based meeting is the key function in co-ordinating the SEA process.1, 9-13
This is where most of the learning and change will take place.
These meetings should be held regularly, for example, a dedicated monthly get-together
over lunchtime or as part of another practice team meeting. Set aside at least one hour
for the meeting. Some minor significant events with obvious solutions can often be dealt
with quickly without much detailed analysis. Others will be much more challenging. Team
members should select a facilitator from within the practice team, although it has been
known for an external facilitator to be appointed in some instances.
The key to an effective SEA is that detailed discussion of each event takes place, insightful
analysis is demonstrated and, where appropriate, learning needs are identified. Relevant
action should be agreed based on this analysis. The meeting should be conducted in an
open, fair, honest and non-threatening atmosphere – this is the core essence and spirit of
the SEA. Failure to do so will hamper the entire SEA process. Where there is a fear of blame
or punishment, team members will become reluctant to engage in the process and
will be more likely to withhold important information about events. The greatest resource
in terms of knowledge, understanding, skills, innovation and effectiveness is the team itself.
The SEA thrives on this. Without these inputs from the team the SEA will be less effective.
Minutes of the meeting – outlining agreed learning points and actions to be taken by
individual staff – should always be taken and circulated afterwards to all staff, including
those not able to attend.
Role of the facilitator10
Before the meeting gets underway the facilitator should explain
their role to the team, which is:
to explain the aims and process of the discussion;
to structure the discussion – keep to time, encourage contributions from all
participants and clarify and summarise frequently;
to maintain basic ground rules, for example, keep things civil, maintain
confidentiality and allow uninterrupted discussion;
to facilitate the investigation and analysis of the event (Stage 4), and
encourage participants to accept responsibility for initiating change;
to recognise emotion within the discussion, to acknowledge it and to allow
appropriate expression within the group;
where practicable, to remain ‘external’ to the team and to avoid giving
unwarranted opinions or colluding with the group during discussions.NHS Education for Scotland 13 Good practice for team-based SEA meetings An SEA can be undertaken at dedicated monthly meetings or as part of regular team- based meetings. Protected time should be set aside to allow detailed discussion and in-depth investigation of events. More serious events should be discussed at specially convened meetings as soon as possible after they happen. Remember to rotate meetings so that part-time staff can also participate. The ground rules for meetings should be agreed and made explicit to team members beforehand, in particular that opinions will be respected, ‘blame’ not apportioned and the purpose of the meeting will be reflection, quality improvement and education. Teams need to be assured (perhaps regularly) that the SEA process is not about allocating blame, but is about gaining a full understanding of why events occur and learning from them. More often than not it will be practice systems and procedures which are deficient – with unfortunate individuals caught up in the process. Where fear of being open and honest about events is apparent, because of potential embarrassment and reprisal, the less effective the SEA will be. Success is heavily reliant on positive team dynamics and interaction. A well-established, strong and cohesive team displaying a high degree of maturity, trust and openness will be well placed to apply the SEA technique effectively. Confidence that frank discussion will not exacerbate interpersonal problems is required. Participants should always refrain from direct personal blame or criticism. Participants need to be clear that discussion and individual feedback should always be positive, fair, constructive and sensitive. Enthusiastic, well-respected and (preferably) trained individuals should be used to promote, co-ordinate and facilitate SEA meetings at the outset. Strong leadership/facilitation is important in running meetings to time, gaining co- operation and agreement, encouraging participation by all members of the team, exposing hidden agendas and in ensuring meetings are not always dominated by a few individuals, particularly medical staff. Employed staff may feel low in the hierarchy, find it difficult to act confidently as equals and feel vulnerable when speaking out. Once the team meetings are well established and team members become more confident and at ease with the process, it may be helpful to rotate the facilitator.
14 Significant Event Analysis Guidance for Primary Care Teams
Stage 4 Analysis of the significant
event
The entire process for analysing a significant event should be guided by
answering the following four key questions:
1. What happened? (also see Stage 2)
Establish what, how and where the event happened in detailed, chronological order.
Focus on collecting as much factual information as possible from:
written and computer records;
personal testimony from those team members directly and indirectly involved,
patients, relatives and colleagues from NHS bodies and other agencies.
Determine what the impact was or could have been (both positive and negative), for
example, clinically and/or emotionally for the patient, the professionalism of individuals
or the team, or the liability of the organisation.
2. Why did it happen?
Establish the main and underlying reasons – positive and negative – contributing
to why the event happened. Identify the problems in administrative, care and
systems processes that led to the incident. For example, these may include, for
whatever reasons, things that should have happened but did not, or did happen as
intended, but something else unexpected interfered with the process.
The majority of significant incidents can often be attributed to a combination of
errors, system deficiencies and other contributory factors. However, many event
investigations are limited by a superficial examination of the underlying causes of
the incident, often focusing exclusively on the role of individual health care workers.
Failing to identify the role of healthcare systems and processes as key causal factors
can result in lost opportunities for learning, improvement and potential recurrence.
There are a number of formal problem solving tools that could help you and your
team to analyze the causes of incidents in a more structured, thorough and effective
manner. The ‘five whys’ (box 1) and ‘fishbone diagrams’ (box 2) are commonly
used methods, which require very little additional training and are straightforward
to apply with practise. The use of both approaches is also illustrated in the SEA
examples outlined in the Appendices.NHS Education for Scotland 15 The five whys The five whys technique starts with a clearly defined problem (in our case: What Happened?). The aim is to attempt to uncover the ‘root’ cause(s) of the problem by repeatedly asking the question ‘why’. By convention the question is asked five times, but there is no maximum or minimum. As you continually ask ‘why’ imagine that you are peeling away causal layers until you reach the underlying processes. The practical steps are illustrated in the clinical example outlined below: The technique has limitations: for example, identified causes can be influenced by the specific questions being posed and who is asking them; additionally this approach may detect only some of the important contributing factors. If the final answer does not feel intuitive or ‘obviously right’ consider a more sophisticated technique such as the fishbone diagram.
16 Significant Event Analysis Guidance for Primary Care Teams
The fishbone diagram
The fishbone diagram is a graphic illustration of the relationship between an incident
and its potential causes. It is used to identify, explore, sort, display and analyze factors
underlying problems. The completed diagram resembles the skeleton of a fish. It can be
drawn by following a few simple steps:
Step 1: Place the identified incident in a box on one side of a page in the ‘head’ of the
fish. Draw the backbone of the fish as a horizontal line from this box across
the page.
Step 2: Identify and label the primary causal factors (categories), each represented as
a ‘rib’. Any number and type or pre-existing categories may be used.
Step 3: Identify secondary and further level causes, indicated by smaller ‘bones’ linked
to each other and the ribs. Individual and group brainstorming may increase
detected causes.
Step 4: Analyze the diagram and attempt to prioritize the causes
The four steps are combined and illustrated through a clinical example below:NHS Education for Scotland 17
3. What has been learned?
Based on the reasons established as to why the event happened, outline the
learning needs identified, if any, from the event
Demonstrate that reflection and learning have taken place on an individual or team
basis and that relevant team members have been involved in the analysis of the
event.
Consider, for instance:
a lack of knowledge and training;
the need to follow systems or procedures;
the vital importance of team working or effective communication.
4. What has been changed or actioned?
Based on the understanding of why the event happened and the identification of
learning needs, outline the action(s) agreed and implemented (where this is relevant
or feasible).
Action is not always necessary – particularly for positive and purely reflective events
– but should always be considered and justifiably ruled out if not necessary.
Consider, for instance, if a protocol has been amended, updated or introduced,
how was this done and who was involved, and how will this change be monitored.
It is also good practice to attach any documentary evidence of change to
the subsequent SEA report, for example, a letter of apology to a patient
or a new protocol.
Consider also how this SEA could be shared and if the event should be formally
reported to a local incident reporting system managed by the NHS Board.18 Significant Event Analysis Guidance for Primary Care Teams
Possible outcomes of a significant event meeting
Celebration ften the care and service provided are shown to
O
be exemplary. For example, the team-based effort in
successfully resuscitating an elderly man who collapsed in
the surgery waiting room.
No action he event is part of everyday practice or is so unlikely to ever
T
happen again that it would not be an effective use of time
and resources putting preventative measures in place.
A learning need patient’s sudden collapse in the surgery revealed that the
A
nurse and doctor who attended needed refresher training in
cardio-pulmonary resuscitation (CPR). Other team members
agreed they needed it too and a session was arranged.
A learning point discharge summary was received in the practice,
A
but the prescriptions on the practice computer were
not changed. An out-of-hours doctor had to sort out the
problem and the patient complained. The doctors agreed to
be more careful in responding to new discharge summaries.
A conventional audit A problem is revealed, but the team is unsure how common
is required it is. For example, a 49 year-old overweight patient and
smoker is admitted to the local hospital with a myocardial
infarction (MI). Review of his records shows that he was
at risk, but was not on appropriate medication.
Immediate change child was given an out-of-date vaccination prompting a
A
complaint from the parents. The practice had an ad-hoc
arrangement for monitoring vaccinations. .
A formal protocol was introduced immediately to
ensure regular checking of vaccinations and refrigerator
temperatures by designated staff.
Further investigation: The team discussed an apparent missing blood test result
in-depth SEA required which had been ordered for an elderly man who was
subsequently hospitalised with anaemia. It was unclear why
this had happened. The GP who ordered the test and the
practice manager would jointly undertake an SEA to fully
investigate.
Sharing the learning s well as sharing the SEA among colleagues in the
A
immediate practice, consideration should also be given to
sharing both the circumstances surrounding the anonymised
event and the associated learning gained from the analysis
with any local forums (for example, GP Trainers’ Groups,
the local health centre, CPD and Protected Learning Time
meetings, Patient Safety Action Teams based in local
healthcare organisations).NHS Education for Scotland 19
Stage 5 Agree, implement and
monitor change
All SEA meetings should start by looking at agreed actions in the minutes
of the last or previous meetings. Action that is agreed as part of an SEA
should be implemented by those staff designated to co-ordinate .
and monitor change, in the same way the practice would act on the
results of the ‘traditional’ audit process. A timescale for change should
always be built in to the process.
Progress with the implementation of change should always be monitored by placing it on
the agenda for future team or significant event meetings. In this way, confirmation that the
change has been implemented can be made or any difficulties in this area can be discussed
and overcome with the help of the team.
Where required, the implementation, monitoring and review of change are vital to the
success of the SEA.14 Like traditional audits, failure to consider change that is necessary
and implement it effectively is a common barrier to successful SEAs in general practice. As
a litmus test to how well an SEA is undertaken, practices should ask themselves: ‘What is
the chance of this event happening again?’20 Significant Event Analysis Guidance for Primary Care Teams
Stage 6 Write it up
Keep a written record of every SEA undertaken using a well
established standardised report format.15
These report formats have been widely used for appraisal purposes by doctors in
training and by other clinical professions as a reflective educational tool. The written report
should be separate from the minutes of meetings, as these notes often lack the depth of
detail that is necessary when keeping a record of an SEA. Remember to update the report
as actions are carried out, or outcomes are achieved, so that the report records the whole
process.
The written SEA report
A comprehensive SEA report needs to be written as soon as possible after the analysis is
completed. When writing a report, bear in mind that it needs to be a sufficiently detailed
account of the entire investigation process, which should cover the following four key
areas:
1 What happened?
2 Why did it happen?
3 What was learned?
4 What was changed? (where appropriate).
The written report is a window on the entire SEA process. It acts as a permanent record
of the event and is evidence of identified learning needs and action taken, if necessary.
If it does not reflect the necessary depth of analysis the event merited, then it is entirely
possible that Quality and Outcomes Framework (QOF) Reviewers, GP Appraisers or
Educators will raise concerns with the standard of the SEA. Regardless of whether a
different report format is in use, detailed information on the four key areas shown above
should be included. It is good practice to avoid using any identifying information for
the patients, members of staff or agencies involved in the event; that is, don’t use first or
second names – instead use codenames such as ‘Patient X’, ‘Dr A’ or ‘Nurse Y’.
Stakeholders who may expect to see anonymised SEA reports include:
Patients and carers;
Educational peer reviewers;
QOF Assessors/Reviewers;
GP Appraisers;
RCGP Quality Practice Awards Assessors/RCGP Practice Accreditation;
Clinical governance committees;
Community Health Partnerships
Vocational Training Scheme for Practice Managers
GP Educational Supervisors;
In time, the General Medical Council (GMC) in revalidation.NHS Education for Scotland 21
Stage 7 Report, share and review
Report and share the learning from significant events
Reporting when things go wrong is essential in general practice, but rarely
happens. The practice should look to formally report and notify (via the
local primary care organisation) those events where patient safety has, or
could have been, compromised
Also, where such a mechanism exists, confidential SEA reports should be passed to local
clinical governance leads so there may be an opportunity for lessons learned to be shared
with others.
For staff and primary care contractors to feel comfortable reporting significant events
or incidents, they must have confidence in the culture: that it is open and fair, and that
staff can feel able to speak up when they have concerns, and where they know they
will be treated fairly if they do so. Creating, nurturing and sustaining that culture is a
responsibility of each and every one of us; as is the responsibility to report significant
events and patient safety incidents.
Nominate a lead to complete a report. Also, share the learning with others. In some
cases the primary care organisation is required to report significant events to external
organisations.
External organisations that might require a report include:
Community Health Partnerships (CHPs)
Medicines and Healthcare products Regulatory Agency (MHRA);
Health and Safety Executive through Reporting of Injuries, Diseases and Dangerous
Occurrences Regulations (RIDDOR);
NHS Boards (NHSScotland).
Which events should be reported?
The NPSA encourages the confidential and anonymous reporting of incidents that caused
no harm to patients, or where harm was averted, as well as events with a serious outcome
which are more likely to be flagged up in existing clinical governance and reporting
systems. It is these prevented patient safety incidents (known as near misses) that can
provide the most valuable learning for the NHS because they can highlight problem areas
where there is the potential for things to go wrong in the future. They can also highlight
ways in which staff have prevented the incident harming the patient (or have minimised
the actual harm caused to the patient), and the NPSA is looking to learn from these
actions to encourage the spread of best practice.
All NHS organisations in the UK should have local arrangements in place to enable
primary care staff to report patient safety incidents.22 Significant Event Analysis Guidance for Primary Care Teams
Quick pointers to writing up SEA
reports and examples
Standardised Standard report formats are strongly recommended for GP Appraisal in the UK
SEA Report and these should be used to record the details and outcomes of SEA attempts by
templates practices (see Examples 1-4).
The lack of standardisation makes it difficult and time-consuming for QOF visitors,
GP Appraisers, primary care organisations and others to analyse and review the
information they contain.
Using a standard report format encourages consistency of approach
and an appropriately detailed SEA account by the practice.
Reports should be typed. Avoid handwriting reports for obvious reasons of
legibility.
Length of There is no standard length of report. However, in most cases, shorter reports (less
SEA reports than one page) are more prone to have important details missing.
Basic A number of significant event reports omit important basic information, such as date of
information event, date of the SEA meeting and the forum where this took place.
This information is important because it would be expected that dates relating
to an event would be provided at third party request (for example, a clinical
governance lead or reporting and learning system). Dates are also important
in assisting teams with action planning and follow-up.
Reflection, The content of SEA reports often focuses largely on what happened.
learning Reports should also demonstrate clearly that practices have determined how and
and change why an event occurred.
The learning needs arising from the analysis and the changes agreed and
implemented by the team should also be stated clearly and in sufficient detail.
‘Negative’ Most practices focus on auditing ‘negative’ significant events, that is, where things
and ‘positive’ have gone wrong or where care could have been better.
significant ‘Positive’ significant events, that is, those where care has been excellent or could be
events shared so others can learn from them, are equally welcome for QOF or appraisal
purposes.
Learning from near misses.
Multi- Avoid carrying out an SEA in isolation or with only a small number of staff,
professional particularly with events that are relevant to the whole team.
involvement Significant events often identify problems between organisations (for example,
hospitals, police, ambulance service, nursing home) which need to be highlighted
and addressed. The SEA process should focus on these events as well as those on
‘internal’ practice affairs.NHS Education for Scotland 23 Example 1 Inappropriate immunization SEA report and educational feedback provided Wrongly administered MMR vaccination 1. What happened? (Describe what actually happened in detail. Consider, for instance, how it happened, where it happened, who was involved and what the impact or potential impact was on the patient, the team, organisation and/or others). A three-month old child attended the combined Child Health Surveillance/Immunisations Clinic to receive her second booster of primary immunisation. The health visitor informed the duty doctor that instead of giving the DTP/Hib vaccine she had wrongly administered an MMR vaccine quite ‘accidentally’. The GP explained to the parents that this was an honest and genuine human error. Understandably the parents were rather alarmed that such an error was made, especially in the wake of media attention and heightened public anxiety about MMR. The GP also contacted the local hospital paediatric consultant who confirmed that there was no real danger to the health of the three- month-old child. The parents needed much reassurance that their child was going to be alright. The GP visited the parents’ house later that evening to check on the child and to see how the parents were coping under the circumstances, and to deal with any other concerns they had regarding the wrong vaccine being administered. This event could have led to a complaint and/or litigation and adverse publicity for the practice, while there was a small chance of a clinical impact on the child. Our HV and PN were upset about the event. 2. Why did it happen? (Describe the main and underlying reasons – both positive and negative – contributing to why the event happened. Consider, for instance, the professionalism of the team, the lack of a system or a failing in a system, lack of knowledge or the complexity and uncertainty associated with the event). Child immunisation had previously been performed by our practice nurse, but due to ever- increasing workloads in other areas of primary care, especially management of chronic diseases, our practice, after discussion with all team members, decided that our health visitor would be trained to take up childhood immunisations. The health visitor attended a course in childhood immunisations and commenced immunisation in the practice around six months ago, but always under the supervision of another qualified health visitor, who has great experience in administering childhood vaccinations in our practice. Both the health visitors’ account of the event was that Ms X had drawn up the solution from the vial. Only after she had administered it and was checking with Ms Y, so that the batch number and expiry date of the vaccine could be recorded in the patient’s case records, did they both discover the now empty vial was actually MMR and they realised that Ms X must have administered MMR to the child instead of the second DTP/Hib booster she was due. Ms X under some distress left the clinic and Ms Y advised the parents of the child to take a seat as she needed to speak to the GP right away.
24 Significant Event Analysis Guidance for Primary Care Teams
Alternative analysis of the event using the ‘five whys’ method
Alternative analysis of the event using a fishbone diagramNHS Education for Scotland 25
It appears that this event has occurred due to a number of possible explanations:
1. Ms X had, instead of drawing up DTP/Hib, unknowingly picked up the MMR that may have been
placed near the other vaccines and drew from the vial.
2. Ms X may have been distracted at the time she picked up and drew from the wrong vaccine,
hence did not realise that it was the wrong one.
3. There was a lack of ‘double checking’ of the vial prior to immunisation by both staff (involuntary
automaticity).
4. There was a lack of communication between the two health visitors at the time and/or with the
parent of the child.
5 There was no formal standard immunisation protocol in place for giving vaccinations.
6. The practice assumed (wrongly) that the local primary care organisation would have trained
both health visitors in following a relevant protocol.
7. As the MMR vaccine is a live attenuated vaccine and grown/cultured in chicken egg yolk, it is
vital and compulsory .
to ask parents of the child being immunised with MMR if the child could possibly be allergic to
eggs.
8. Since Ms X had not realised she had drawn up the MMR vaccine she had obviously not asked
the parents regarding any possibility of allergy to the component.
3. What has been learned?
(Demonstrate that reflection and learning have taken place on an individual or
team basis and that relevant team members have been involved in the analysis
of the event. Consider, for instance: a lack of education and training; the need to
follow systems or procedures; .
the vital importance of team working or effective communication).
The existing process of immunisation failed to properly protect the safety of a child. The
team agreed that a key learning point was actually the lack of a formal, reliable and robust
immunisation system.
The practice learned that because of this system issue, it was inevitable that errors would
happen.
All persons administering vaccinations should be fully aware of the immunisation system and
should refer to it frequently and especially prior to administration of each vaccination.
There was a lack of communication between staff and between staff and parents.
The combined clinics and volume of associated workload contributed to the error.
The practice assumed the local primary care organisation would have organised training and
developed a protocol to be followed and would be responsible for this. Responsibility and
liability is also an issue for the practice.26 Significant Event Analysis Guidance for Primary Care Teams
4. What has been changed?
(Outline the action(s) agreed and implemented, where this is relevant or
feasible. Consider, for instance: if a protocol has been amended, updated or
introduced; how was this done and who was involved; how will this change
be monitored. It is also good practice to attach any documentary evidence of
change e.g. a letter of apology to a patient or a new protocol).
This event was further discussed at the next (weekly) practice meeting. It was stressed to all
team members the seriousness of this type of error and possible consequences, in particular
anaphylactic reactions of the child, but also litigation from the family of the child and ways to
prevent this from ever occurring again. After the team investigation the following changes were
put in place:
A routine check-list for the immunisation clinic was developed and introduced (attached),
which was laminated and put up at the place of immunisation. It was added to the practice
protocols folder and the new staff induction pack.
In the fridge, one designated and clearly marked shelf would hold all the childhood
vaccinations.
Work surfaces kept clean and with a good overview of different vaccines.
Separate designated immunisation clinics were introduced to allow more time for vaccination
and recording.
The senior GP partner sent a letter of apology to the family concerned and informed them
that an internal investigation had led to a new immunisation system being introduced.
The vaccination issue will be monitored at future SEA meetings until the practice is satisfied
that learning and change have taken hold and the new system is working effectively.
What was effective about this SEA?
This was a significant event for the practice and merited further analysis.
A clear description of the event was provided, including the roles of all individuals
involved and the setting in which the event took place.
The impact and other potential consequences of the event were clearly stated.
A number of issues which contributed to the event were documented, which provide
insights into why this event actually happened.
The analysis of the event by the team demonstrated that clear reflection and learning
had taken place which was relevant and informed what actions would have to be taken.
The actions taken are already in place and are appropriate in the circumstances. These
are an improvement on previous practices and should help to reduce the chance of a
similar event occurring again.NHS Education for Scotland 27 Example 2 Delayed diagnosis SEA report and educational feedback provided Misfiled report 1. What happened? (Describe what actually happened in detail. Consider, for instance, how it happened, where it happened, who was involved and what the impact or potential impact was on the patient, the team, organisation and/or others). Failed to pass complete haematology report to patient, and failure to act on blood report. Patient had attended local surgery on feeling tired and unwell. Post-viral symptoms? Full blood count was sent off by Treatment Room Sister. When the patient phoned for the result a few days later the report was not to hand, so Dr X obtained counts from the laboratory by phone. The only abnormality was a WBC of 11.59; otherwise FBC and ESR were normal. This was given to the patient as a reasonable result for a post-viral illness. Only subsequently was the printed FBC report received, with a written advice report, ‘Lymphocytes with activated forms…suggest repeat in two-three weeks’. This report was marked by Dr Y as ‘Dr will speak to patient’ and filed. Dr Y did not know that Dr X had given the patient a verbal report over the phone. The patient was not informed further as the patient thought that he already had the full report. The patient returned to surgery nearly five months later with a cough, when another local saw the report, told the patient that a repeat blood had been advised and was overdue, and repeated the FBC. This showed a persistent high WBC of 14.98 and features, which were later confirmed to be Chronic Lymphatic Leukaemia. 2. Why did it happen? (Describe the main and underlying reasons – both positive and negative – contributing to why the event happened. Consider, for instance, the professionalism of the team, the lack of a system or a failing in a system, lack of knowledge or the complexity and uncertainty associated with the event). The incident was discussed in detail at a weekly practice meeting. It happened because the report was given to the patient on the basis of a telephone report from the laboratory, probably with counts taken from the laboratory computer. The haematologist’s written advice was not given and was probably not available at the time the report was given by the laboratory over the phone. The report was obtained from the laboratory by our receptionist, it is possible that the written advice report would have been given if a doctor had phoned for the report. Results of blood tests initiated by a locum are more difficult to handle as there is a lack of ownership of the result. Very often, if results are abnormal, but not too drastic, we rely on the patient to phone back in to get the result. The report is marked, ‘Dr will speak to patient’.
28 Significant Event Analysis Guidance for Primary Care Teams
Alternative analysis of the event using the ‘five whys’ method
Alternative analysis of the event using a fishbone diagramNHS Education for Scotland 29 3. What has been learned? (Demonstrate that reflection and learning have taken place on an individual or team basis and that relevant team members have been involved in the analysis of the event. Consider, for instance: a lack of education and training; the need to follow systems or procedures; the vital importance of team working or effective communication). The whole process of issuing results to patients over the phone was reviewed. We have advised extreme caution in results obtained over the phone as these may be incomplete and a receptionist may not get as full a result as a doctor. If a patient is given a result which has come verbally over the phone, the patient should be asked to phone for confirmation of the result of this when the report comes in writing. Alternatively, the doctor giving the result should be responsible for checking that the subsequent written report contains no additional items of importance. Caution also must be exercised over results of tests initiated by a locum. A new procedure is that whenever a result is marked ‘Dr will speak to patient’, the doctor must initial this. This lets the receptionist know which doctor to refer to, but also gives the doctor a sense of ownership of the result, and a sense of responsibility for transmission of the result to the patient. If a laboratory report advises a definite repeat test in a particular time interval, we now are inclined to the view that we should contact the patient by letter or phone to ensure the patient has the advice.
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